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NCT04737512 · ClinicalTrials.gov registry record · Early Phase 1
Mindfulness-Based ADHD Treatment for Children: a Feasibility Study
A Early Phase 1 study of Attention Deficit Hyperactivity Disorder, sponsored by Yale University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 68
- Enrollment target
- 1
- Study location
NCT04737512: Completed Early Phase 1 study of Attention Deficit Hyperactivity Disorder, sponsored by Yale University.
NCT04737512 is a Early Phase 1 study of Attention Deficit Hyperactivity Disorder that has completed, run by Yale University. The registered enrollment target is 68 participants, below the 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04737512, a Early Phase 1 study of Attention Deficit Hyperactivity Disorder, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 68 participants
- Enrollment target
- 1
- Study location
Study Summary
Attention-Deficit/Hyperactivity Disorder (ADHD) affects 11% of children and leads to adverse outcomes. Medications, while often effective in reducing certain ADHD symptoms, have many disadvantages, including misuse and side effects. Behavioral interventions do not have these adverse effects, but they are not as effective. Mindfulness is a candidate intervention for ADHD in elementary school children, but has not been systematically and rigorously studied. This study will evaluate the feasibility and acceptability of Mindfulness-Based ADHD Treatment for Children (MBAT-C). MBAT-C is designed for children at precisely the age when ADHD-relevant neurocognitive systems are developing and clinical symptoms begin to appear. Forty-five children from the New Haven, CT area, ages 7-13, will be recruited to participate in this randomized-controlled feasibility trial that will compare MBAT-C, medication, and a combined intervention.
Primary Outcome
Total number of participants enrolled
Conditions Studied
Interventions
- BEHAVIORAL Mindfulness-Based ADHD Treatment for Children
- BIOLOGICAL Goal-Standard Medication (Treatment as Usual)
Study Locations (1)
Connecticut
- Clinical & Affective Neuroscience Lab - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2024-10-29 |
| Phase | Early Phase 1 |
What the finished NCT04737512 record still lists
NCT04737512 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 2 interventions - of which Mindfulness-Based ADHD Treatment for Children is the first listed.
NCT04737512 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT04737512 about?
NCT04737512 is a clinical study titled "Mindfulness-Based ADHD Treatment for Children: a Feasibility Study". Attention-Deficit/Hyperactivity Disorder (ADHD) affects 11% of children and leads to adverse outcomes. Medications, while often effective in reducing certain ADHD symptoms, have many disadvantages, including misuse and side effects. Behavioral interventions do not have these adverse effects, but the...
What is the current status of trial NCT04737512?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 68 participants. The study started on 2021-02-01. Estimated completion is 2024-10-29.
What conditions does trial NCT04737512 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder.
What interventions are being tested in trial NCT04737512?
The interventions under investigation include: Mindfulness-Based ADHD Treatment for Children (BEHAVIORAL), Goal-Standard Medication (Treatment as Usual) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04737512?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04737512 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04737512's enrollment target sits among peer trials
68 55th of 102 higher than 48 of 102 other Attention Deficit Hyperactivity Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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